← Back to catalogue
Comfort Face Tent (Adult), elastic strap style
EUDAMEDClass IIb (EU MDR)
Ref 1110-0-50Model Salter Labs Aerosol Masks
by Salter Labs
Identity
- Trade Name
- Comfort Face Tent (Adult), elastic strap style EUDAMED
- Model / Reference
- Salter Labs Aerosol Masks EUDAMED1110-0-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411301206 EUDAMED
- Basic UDI-DI
- 0607411TF20013aAersMaskM5 EUDAMED
- Unit of Use DI
- 00607411301209 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Comfort Face Tent (Adult), elastic strap style by Salter Labs — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0607411TF20013aAersMaskM5 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 68f60267-2826-46db-b714-49a34f1300dd 61 fields · synced Aug 1, 2026